Healthy Participants, Systemic Lupus Erythematosus
Conditions
Brief summary
This is a study to investigate the experimental medication BMS-986165 in healthy participants in order to study the effects it has on electrocardiogram results.
Interventions
DRUGBMS-986165
Specified dose on specified days
DRUGMoxifloxacin
Specified dose on specified days
OTHERPlacebo
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Healthy as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations in the opinion of the investigator * Body mass index of 18.0 to 32.0 kg/m2, inclusive, and body weight ≥ 50 kg, at screening * Normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) \> 80 mL/min/1.732 m2
Exclusion criteria
* Any medical condition that presents a potential risk and/or may compromise the objectives of the study, including a history or presence of active liver disease * A personal history of clinically relevant cardiac disease as determined by the investigator, symptomatic or asymptomatic arrhythmias, presyncope or syncopal episodes, or additional risk factors for torsades de pointes (eg, heart failure) * History of hypokalemia, personal history or family history of prolonged QT interval, or family history of sudden cardiac death at a young age Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Placebo-corrected change from baseline in (Fridericia) QT Interval (QTcF) for BMS-986165 as determined by 12-lead electrocardiogram (ECG) | From baseline to 5 days |
Secondary
| Measure | Time frame |
|---|---|
| Placebo-corrected change from baseline in corrected (Fridericia) QT Interval (QTcF) for moxifloxacin as determined by 12-lead ECG | From baseline to 5 days |
| Heart rate (HR) as determined by 12-lead ECG | 5 days |
| QRS as determined by 12-lead ECG | 5 days |
| Incidence of serious adverse events (SAE) | Up to 28 days |
| PR as determined by 12-lead ECG | 5 days |
| Incidence of adverse events (AE) | Up to 28 days |
| Incidence of participant abnormalities in vital signs, clinical laboratory tests, safety 12-lead ECGs, and physical examinations | Up to 28 days |
| Maximum observed concentration (Cmax) as determined by plasma concentration | 5 days |
| Time of maximum observed concentration (Tmax) as determined by plasma concentration | 5 days |
| Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] as determined by plasma concentration | 5 days |
| Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] as determined by plasma concentration | 5 days |
| Change from baseline in corrected (Fridericia) QT Interval (QTcF) as determined by 12-lead ECG | From baseline to 5 days |
Countries
United States
Outcome results
None listed